Rivastigmine (Transdermal route)

Pronunciation:

Brand Names:

Exelon

Dosage Forms:

Patch, Extended Release

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Cholinesterase Inhibitor, Centrally Acting

Uses of This Medicine:

Rivastigmine patch is used to treat dementia (memory loss) associated with mild, moderate, or severe Alzheimer's disease, or mild to moderate dementia associated with Parkinson's disease. Rivastigmine will not cure these diseases and it will not stop these diseases from getting worse. However, rivastigmine can improve thinking ability in some patients with these diseases.

In Alzheimer's disease, many chemical changes take place in the brain. One of the earliest and biggest changes is that there is a decrease in a chemical called acetylcholine (ACh). ACh helps the brain to work properly. Rivastigmine is an acetylcholinesterase inhibitor. It slows the breakdown of ACh, so it can build up and have a greater effect. However, as Alzheimer's disease gets worse, there will be less and less ACh, so rivastigmine may not work as well.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of rivastigmine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rivastigmine in the elderly.

Pregnancy—

Pregnancy Category

Explanation

All Trimesters

B

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Metoclopramide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acrivastine

Bupropion

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Oxybutynin

Tolterodine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma, history of or

Chronic obstructive pulmonary disease (COPD), history of or

Heart block or

Seizures or tremors or

Sick-sinus syndrome (heart rhythm problem) or

Stomach or bowel ulcers or

Urinary tract blockage or difficult urination—Use with caution. This medicine may worsen these conditions.

Kidney disease, moderate to severe or

Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of this medicine from the body. Use of a lower dose may be needed.

Low body weight (below 50 kilograms)—Use with caution. The side effects of this medicine may be increased. Use of a lower dose may be needed.

Proper Use of This Medicine:

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

To use the skin patch:

Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.

Apply the patch to a clean, dry, and hairless skin area on your upper or lower back, upper arm, or chest. Do not put the patch over rashes, cuts, or irritated skin. Avoid putting the patch on areas where it could be rubbed off by tight clothing.

Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.

Press the patch firmly in place for 30 seconds with the palm of your hand to make sure that the edges of the patch stick well.

The patch should stay in place, even when you are showering, bathing, or swimming. Apply a new patch if it falls off.

After 24 hours, remove the patch. Choose a different place on your skin to apply the new patch. Do not put a new patch in the same place for at least 14 days. Do not leave the patch on for more than 24 hours. It will not work as well after that time and it may irritate your skin.

After removing a used patch, fold the patch in half with the sticky sides together. Place the folded, used patch in its protective pouch. Make sure to dispose of it out of the reach of children and pets.

Try to change the patch at the same time each day. If you forget to change the patch at the usual time, remove the patch you are wearing and put on a new patch. After that, apply a fresh patch at the usual time on the next day.

Do not put cream, lotion, ointment, oil, or powder on the skin area where the patch will be placed.

Do not touch your eyes after you touch the patch.

Do not expose the patch to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or direct sunlight for long periods of time.

Make sure you wash your hands with soap and water before and after applying the patch.

Do not stop using this medicine without asking your doctor. If you have not used your medicine for several days in a row, do not start using it again without talking to your doctor first. You may need to start the medicine again using a lower dose.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For transdermal dosage form (patch):

For dementia associated with Alzheimer's disease or Parkinson's disease:

Adults—At first, one 4.6 milligram (mg) patch once a day. After at least 4 weeks, your doctor will increase your dose as needed. If you have mild to moderate Alzheimer's disease or Parkinson's disease dementia, usual dose is 9.5 mg patch or 13.3 mg patch per day. If you have severe Alzheimer's disease, 13.3 mg patch per day. However, the dose is usually not more than one 13.3 mg patch per day.

Children—Use and dose must be determined by your doctor.

Missed dose—

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

If you go 3 days in a row or longer without wearing a patch, do not apply a new one until you have talked to your doctor. You might need to go back to a lower dose.

Storage—

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

This medicine may cause serious skin reactions such as blistering, burning, crusting, dryness, flaking, itching, scaling, severe redness, soreness, or swelling of the skin. Call you doctor right away if these skin reactions spread beyond the patch size, if they get worse, or if symptoms do not improve within 48 hours after removing the patch.

Having more than one patch on your body at the same time can cause you to get too much of this medicine. Make sure you remove the used patch before wearing a new one to decrease your risk of having serious side effects. If you accidentally use more than one patch at a time, call your doctor right away.

This medicine may cause nausea, severe vomiting, loss of appetite, diarrhea, and weight loss. Talk with your doctor before using this medicine if you have any concerns. Call your doctor right away if you have severe diarrhea, dry mouth, thirst, unusual tiredness, and less urine than usual. These could be symptoms of dehydration (loss of too much body fluid). Dehydration is more likely to occur if you have diarrhea or vomiting.

This medicine may also increase your risk of having seizures or tremors, stomach or bowel bleeding or ulcers, heart rhythm problems, bladder or urinating problems, or lung or breathing problems. Talk with your doctor before using this medicine if you have any concerns.

Before you have any kind of surgery or dental treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Using rivastigmine together with medicines that are sometimes used during surgery or dental treatments may increase the effects of these medicines.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

lower back or side pain

Less common

Blurred vision

dizziness

headache

loss of bladder control

nervousness

pounding in the ears

slow or fast heartbeat

Rare

Abdominal or stomach pain or tenderness

arm, back, or jaw pain

chest pain, tightness, heaviness, or discomfort

confusion

convulsions

decreased urine

difficult or troubled breathing

dilated neck veins

extreme fatigue

false beliefs that cannot be changed by facts

irregular breathing

irregular heartbeat

loss of consciousness

rapid breathing

seizures

severe nausea or vomiting

shortness of breath

sunken eyes

swelling of the face, fingers, feet, or lower legs

wrinkled skin

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

burning, itching, redness, skin rash, swelling, or soreness at the application site

fast, pounding, or irregular heartbeat or pulse

hives or welts

itching

itching, scaling, severe redness, soreness, or swelling of the skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

increasing muscle weakness

irregular, fast or slow, or shallow breathing

pale or blue lips, fingernails, or skin

slow or irregular heartbeat

sweating

unusual tiredness or weakness

watering of mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

discouragement

fear

feeling of constant movement of self or surroundings

feeling sad or empty

irritability

lack of appetite

lack or loss of strength

loss of interest or pleasure

nausea

redness at the application site

sensation of spinning

stomach pain

tiredness

trouble concentrating

trouble sleeping

upper stomach pain

vomiting

weight loss

Rare

Blindness

burning, stinging, or pain at application site

continuing ringing or buzzing or other unexplained noise in the ears

decreased vision

difficulty with moving

eye pain

hearing loss

itchy skin

muscle pain or stiffness

pain in the joints

pale skin

tearing

troubled breathing with exertion

unusual bleeding or bruising

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.